U. S. Food and Drug Administration
Press Handout: December 5, 1995

(This document also available in other languages.)

THE PROVISIONS OF THE REGULATION
THE SEAFOOD HACCP REGULATIONS

1. Coverage

a. All "processors"

All seafood-related entities in our establishment inventory. All foreign processors that export to U.S.

Exempt:

Fishing vessels
Common carriers
Retail

b. All importers

2. Hazard Analysis (HACCP PRINCIPLE #1)

a. Every "processor" must conduct a hazard analysis to determine whether they have likely food safety hazards that they must control.

If no: they do not need a HACCP Plan for the time being (assuming they're right). They must reassess, however, whenever a significant change occurs.
If yes: they must have and implement a HACCP plan.

3. The HACCP plan

a. Where hazard analysis reveals need, every "processor" must have a written HACCP plan that's specific to location and kind of product.

b. HACCP plan must ID:

i. Food safety hazards that are reasonably likely to occur.

These include anything that causes a food to be unsafe under the act, e.g., toxins, micro, chemicals, pesticides, drug residues, physical hazards, decomposition.

ii. Critical control points to control hazards that can occur both inside & outside the processing plant. (HACCP PRINCIPLE #2)

iii. Critical limits (i.e., safe operating parameters) for the ccp's. (HACCP PRINCIPLE #3)

iv. Monitoring procedures. (HACCP PRINCIPLE #4)

v. Corrective action plans, if any. (HACCP PRINCIPLE #5)

vi. Verification procedures to: (HACCP PRINCIPLE #6)

Two purposes:

Ensure HACCP plan is up to date, at least annually.
Ensure ongoing implementation is OK.

vii. Recordkeeping system to document monitoring, corrective actions, certain verification procedures. (HACCP PRINCIPLE #7)

c. Signing/dating: Plan must be signed/dated by a senior firm official. This must occur initially, upon modification, and at least annually.

4. Corrective Actions

Processors may either...

a. Follow corrective action plans they have developed in advance,

b. Do the following:

Segregate & hold product while determining acceptability of product for distribution. (Must use person with adequate training or experience.)
Take necessary corrective action;
Check the plan to see if it needs to be modified; modify as necessary. (Must use trained individual.)

5. Verification

a. Verifying the HACCP plan: Processors must reassess adequacy of their HACCP plan at least annually or whenever a significant change occurs.

b. Verifying ongoing activities:

i. Processors must follow written verification procedures that are in their HACCP plans for reviewing consumer complains, calibrating their monitoring devices, engaging in any end-product testing.

ii. Processors must review monitoring & corrective action records within one week of the creation of the records, and must review calibration & end-product testing records within a reasonable time.

iii. Processors must check whether their consumer complaints that allege safety problems reveal any problems with their HACCP systems that must be fixed.

6. Records

a. Monitoring and similar records must state the name & location of the processor, date & date, signature/initials of person making the record.

b. Records retention: processors must store records for 1 to 2 years, depending on type of record and type of product (i.e., shelf-life).

c. Plans, HACCP records, & sanitation records, must be available to FDA inspectors for review and copying. Consumer complaints are not available, but the consumer complaint SOP is available.

d. All plans & records in possession of FDA are deemed to be not available for public disclosure per FOIA regulations. Exceptions: 1) previously disclosed or abandoned materials; 2) discretionary disclosure in accordance with FDA's FOIA regulations.

7. Training

a. For each processor, certain enumerated HACCP functions must be performed by an individual who has been trained in HACCP through course materials or who through job experience that has provided knowledge equivalent to a course. The course must be at least equivalent to a standard curriculum recognized as adequate by FDA.

b. The enumerated functions are:

Developing the HACCP plan or adopting a generic-type HACCP plan to fit the specific needs of a processor.
Reassessing/modifying the HACCP plan as a result of verification activities and any corrective actions that occur.
Reviewing HACCP records for adequacy.

c. Processors have a choice: they may either obtain training for one or more of their own employees, or they may hire trained independent contractors to perform these functions.

8. Sanitation

a. Monitoring/Recordkeeping. Processors must monitor and keep records in 8 enumerated areas of sanitation. Processors may establish their own monitoring frequencies. This monitoring and recordkeeping may be part of the processor's HACCP system or in a parallel system outside the HACCP plan. FDA has access to these records. The regulations recommend that processors have a sanitation SOP for the 8 enumerated areas, but it is not required.

9. Special Requirements for Imports

a. Importers must verify that their overseas suppliers follow HACCP. There are two ways to verify:

i. Obtain product from a country with which the U.S. has a HACCP-based agreement re the equivalency of inspection programs.

ii. Implement verification procedures:

product specifications for safety.
affirmative steps to ensure that HACCP was actually practiced. Any of the following:
- obtaining processor's HACCP and sanitation records;
- obtaining third party certification that product is processed according to requirements;
- going overseas and inspecting facilities to ensure product is processed according to requirements;
- obtaining a copy of processor's HACCP & a guarantee that it is being followed;
- end-product testing & obtaining a guarantee that plan is being followed.

10. Special Requirement for Molluscan Shellfish

a. Controlling the origin of molluscan shellfish (i.e., properly classified waters) is most important preventive control for most hazards. Thus, the HACCP plans of processors of molluscan shellfish must include how this control is being performed, including how processor are only obtaining shellfish:

From waters approved by a "shellfish control authority."
From harvesters who are in compliance with local licensure requirements.
If properly "tagged."

11. Special Requirement for Smoked Fish

a. Botulism is a significant likely hazard for this type of product if not sufficiently controlled. Thus, the HACCP plans of processors of smoked fish must include how they are controlling this hazard to ensure zero toxin production in the product for a time slightly beyond the shelf life of the product.

12. Time Frame for Implementation

a. The industry has two years to obtain training, write HACCP plans, install HACCP systems, engage in sanitation monitoring, etc. FDA is preparing to conduct voluntary, "dry run" HACCP inspections during this two year period. Full, mandatory implementation must occur by the end of this period.

Seafood HACCP

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U. S. Food and Drug Administration Press Handout: December 5, 1995

THE PROVISIONS OF THE REGULATION THE SEAFOOD HACCP REGULATIONS